Medicines, 2025
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765 medicine recalls FDA’s Enforcement Report published in 2025, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
765of 765 medicine recallsshown with your filters
The list
- Medicine recall niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance. Class IIFDA’s classMay 7, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereFlorida and Mississippi
- Medicine recall Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery… Class IIFDA’s classMay 7, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 7, 2025ClassClass IIStatusOngoingWhereFlorida and Mississippi
- Medicine recall Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial Lack of assurance of sterility. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial Lack of assurance of sterility. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials Lack of assurance of sterility. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Glycopyrrolate, 1mg per 5mL Lack of Assurance of Sterility: Leaking/damaged syringes. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall dexmedeTOMIDine HCl PF Lack of Assurance of Sterility: Leaking/damaged syringes. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall PHENYLephrine HCl Lack of Assurance of Sterility: Leaking/damaged syringes. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ketamine HCl 50mg per 5mL Lack of Assurance of Sterility: Leaking/damaged syringes. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rocuronium Bromide 50 mg per 5mL Lack of Assurance of Sterility: Leaking/damaged syringes. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Hemopropin Ointment, Lanolin 17.76% and Petrolatum 71.2% CGMP Deviations Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportArizonathe one state its words name PublishedApr 30, 2025ClassClass IIStatusOngoingWhereArizona
- Medicine recall Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03% CGMP Deviations Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportArizonathe one state its words name PublishedApr 30, 2025ClassClass IIStatusOngoingWhereArizona
- Medicine recall clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during… Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle CGMP Deviations Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedApr 30, 2025ClassClass IIStatusOngoingWherePennsylvania
- Medicine recall DoloDent Maximum Strength Toothache Drops, Homeopathic Oral Drops, 0.50 oz fl cGMP deviations Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportDelawarethe one state its words name PublishedApr 30, 2025ClassClass IIStatusTerminatedWhereDelaware
- Medicine recall DoloEar Earache Drops, Homeopathic, 0.50 oz fl cGMP deviations Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportDelawarethe one state its words name PublishedApr 30, 2025ClassClass IIStatusTerminatedWhereDelaware
- Medicine recall Kingskin, Elimina Las Verrugas, For the removal of common warts, 0.50 oz fl cGMP deviations Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportDelawarethe one state its words name PublishedApr 30, 2025ClassClass IIStatusTerminatedWhereDelaware
- Medicine recall Rapidol Arnica Gel, Topical Gel, Homeopathic Medicine, 2 oz cGMP deviations Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportDelawarethe one state its words name PublishedApr 30, 2025ClassClass IIStatusTerminatedWhereDelaware
- Medicine recall Rapidol Arnica Tablets, Homeopathic Medicine, 100-count bottle cGMP deviations Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportDelawarethe one state its words name PublishedApr 30, 2025ClassClass IIStatusTerminatedWhereDelaware
- Medicine recall Urodel, Urinary Tract Infection Symptoms Relief, Homeopathic, 30 chewable tablets per bottle cGMP deviations Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportDelawarethe one state its words name PublishedApr 30, 2025ClassClass IIStatusTerminatedWhereDelaware
- Medicine recall HYDROmorphone Hydrochloride 50mg/50mL Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification.. Class IIIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC… CGMP Deviations Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count… CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Class IIFDA’s classApr 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended… Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Testosterone Cypionate Injection, USP, CIII, 200mg per mL cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall CIPROFLOXACIN OPHTH SOLUTION, 0.3% 5mL bottle Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle Class IIFDA’s classApr 23, 2025in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereAlabama, California, Florida, Georgia and Idaho
- Medicine recall Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit Class IIFDA’s classApr 23, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 23, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Venlafaxine Tablets, USP, 75 mg, 100 Tablets Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet. Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Gabapentin Capsules, USP 300 mg Cross Contamination Class IIIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Gabapentin Capsules, USP 400 mg Cross Contamination Class IIIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton. Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Fenofibrate Capsules 67 mg, USP, 100-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC… CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Voriconazole Tablets 200 mg, 30-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Voriconazole Tablets 50mg, 30-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Gabapentin Tablets 600mg, 500-count bottles CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lacosamide Tablets 200mg, 60-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Frovatriptan Succinate Tablets 2.5mg, 9-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Rufinamide Tablets 200mg, 120-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Nitroglycerin Sublingual Tablets 0.4MG 100-count carton CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Pravastatin Sodium Tablets 80mg, 90-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle CGMP Deviations Class IIFDA’s classApr 16, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 16, 2025ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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